Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Neurology ×
6,334 results
2017–2040 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 22, 2014
PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 220d
Cleared Aug 22, 2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III...
K141446 · GWJ
Natus Medical Incorporated
Neurology · 81d
Not Cleared Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
DEN120017 · PCB
Medtronic Neurosurgery
Neurology · 609d
Cleared CT Aug 08, 2014
WALKAIDE SYSTEM
K140886 · GZI
Innovative Neurotronics, Inc.
Neurology · 123d
Cleared Aug 06, 2014
IQ TECHNOLOGIES
K131290 · NUH
Iq Technologies, Inc.
Neurology · 457d
Cleared Jul 31, 2014
TRAXCESS 14 GUIDEWIRE
K133725 · MOF
MicroVention, Inc.
Neurology · 237d
Cleared Jul 25, 2014
BNA ANALYSIS SYSTEM
K121119 · OLU
Eiminda , Ltd.
Neurology · 834d
Cleared Jul 25, 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720 · GXY
Hivox Biotek, Inc.
Neurology · 408d
Cleared Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Jul 23, 2014
CADWELL SPIKE AND SEIZURE DETECTOR
K140552 · OMB
Cadwell
Neurology · 141d
Cleared Jul 23, 2014
DYNAMIC NEUROSCREENING DEVICE
K141208 · LQW
Prosenex
Neurology · 75d
Cleared Jul 21, 2014
BABYMEG BIOMAGNETOMETER SYSTEM
K133419 · OLY
Tristan Technologies, Inc.
Neurology · 256d
Cleared Jul 18, 2014
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200 · GXZ
Neuroinvent, Inc.
Neurology · 172d
Cleared Jul 11, 2014
VIMOVE
K131094 · IKN
Dorsa VI Pty., Ltd.
Neurology · 449d
Cleared Jul 11, 2014
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
K131513 · GZJ
Ritm Okb Zao
Neurology · 409d
Cleared Jul 11, 2014
NEUROPACE BURR HOLE COVER
K141368 · GXR
NeuroPace, Inc.
Neurology · 49d
Cleared Jul 03, 2014
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
K131923 · GZI
Techlink International
Neurology · 372d
Cleared Jul 03, 2014
ASCEND
K140333 · NUH
Neurometrix, Inc.
Neurology · 143d
Cleared Jul 03, 2014
POD SYSTEM
K141134 · HCG
Penumbra, Inc.
Neurology · 63d
Cleared Jul 02, 2014
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452 · GWO
Jeil Medical Corporation
Neurology · 30d
Cleared Jun 27, 2014
HICUT HIGHSPEED INSTRUMENT
K130755 · HBE
Adeor Medical AG
Neurology · 465d
Cleared Jun 27, 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650 · NUH
Hivox Biotek, Inc.
Neurology · 106d
Cleared Jun 27, 2014
P-STIM
K140788 · BWK
Biegler GmbH
Neurology · 88d
Not Cleared Jun 26, 2014
REWALK
DEN130034 · PHL
Argo Medical Technologies, Inc.
Neurology · 374d